ISO 13485:2016 Certified
Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s lifecycle, including service and delivery.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
ISO 9001:2015 Certified
ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. These quality management principles include customer focus, leadership, engagement of people, process approach, improvement, evidence-based decisioning and relationship management.
ISO14001:2015 Certified
ISO 14001 is the internationally recognized standard for environmental management systems (EMS). It provides a framework for organizations to design and implement an EMS, and continually improve their environmental performance. By adhering to this standard, organizations can ensure they are taking proactive measures to minimize their environmental footprint, comply with relevant legal requirements, and achieve their environmental objectives. The framework encompasses various aspects, from resource usage and waste management to monitoring environmental performance and involving stakeholders in environmental commitments.
CCC Certified
CCC certification is a mandatory certification system for products sold in the Chinese Mainland market, which is required by the Chinese government. All products listed in the CCC directory and sold in China, whether domestically produced or imported, need to obtain CCC certification, except for products for special purposes (products that meet the requirements for exemption from CCC certification). CCC certification is a product certification implemented by a nationally recognized certification body. Official certification, also known as market access administrative licensing, is the licensing management implemented by national administrative agencies in accordance with the law for projects listed in the administrative licensing directory. All projects that require official certification must obtain administrative licensing before they can be allowed to produce, operate, store or sell. Administrative licensing targets products, but assesses the management system. Administrative licensing includes domestic products (domestically produced and sold domestically and imported and sold domestically) and exported products (domestically produced and exported products). Food Quality and Safety (QS) certification and Good Manufacturing Practice (GMP) certification are both official certifications.
IPC-A-610E, 620 Class I, II Compliant
IPC classes, with regard to the Assembly Standard 610 are used to standardize the acceptability levels of electronics. The standard is a tool to establish a level of quality and communicate quality acceptance criteria across the industry. The secondary purpose, for a company like Versa Electronics, is to ensure we understand the cost and inspection controls needed to support customers. What might be a ‘process indicator’ to one customer is a ‘defect’ to another customer. The standard level of control is best defined with IPC 610 Assembly Standardization.
SMTA Corporate Member
The Surface Mount Technology Association (SMTA) is a non-profit international association of companies and individuals involved in all aspects of the electronics industry. The Association is dedicated to the advancement of the electronics industry through member education and interaction.
Certifications & Compliance
DYC Electronic has established a comprehensive technology research and development system.
✔ CCC certification
✔ ISO9001:2015 system certification
✔ ISO14001:2015 system certification
✔ ISO13485:2016 system certification
✔ IATF16949 system certification
✔ Supply chain management system
✔ MES process traceability system
✔ Environmental management system
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